A Study of Docetaxel Plus Carboplatin in Patients With Hormone Refractory Prostate Cancer
Information source: Dana-Farber Cancer Institute
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Docetaxel (Drug); Carboplatin (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Dana-Farber Cancer Institute
Official(s) and/or principal investigator(s):
William K Oh, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
The purpose of this study is to look at the effects (good and bad) of the combination of
docetaxel and carboplatin for patients who have progressive prostate cancer after
chemotherapy with drugs such as docetaxel. The investigators are also studying whether the
measurement of two proteins in the blood may predict who will respond to the combination of
docetaxel and carboplatin.
Official title: A Phase II Study of Docetaxel Plus Carboplatin in Hormone Refractory Prostate Cancer Patients Refractory to Prior Docetaxel-Based Chemotherapy
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The primary objective is to determine the efficacy and safety of docetaxel plus carboplatin as salvage chemotherapy in patients with hormone refractory prostate cancer who have progressed on prior docetaxel-based chemotherapy.
Secondary outcome: The secondary objective is to correlate the clinical and prostate-specific antigen (PSA) response with baseline serum chromogranin A (CGA) and neuron-specific enolase (NSE) levels.
Patients will receive both carboplatin and docetaxel. This treatment is given in the
outpatient department once every 3 weeks (called one cycle).
One day prior to the day of chemotherapy, patients are given a steroid drug (dexamethasone)
to be taken twice a day for 3 days. This helps to decrease the risk of an allergic
On the day of chemotherapy, both docetaxel and carboplatin will be given through a vein over
two to three hours. Docetaxel will be given before carboplatin. In addition, patients
receive zofran, an anti-vomiting agent, to try to prevent nausea and vomiting. Study
participants are also given a prescription for anti-nausea pills to take at home.
After each cycle of treatment, patients are required to get their bloods checked (between
days 8-12 of the cycle). This may be done at an outside laboratory closer to the patient's
Treatment will be repeated every three weeks provided the blood tests and physical
examination done prior to each treatment are acceptable. If a patient is not able to receive
the next scheduled dose of chemotherapy, the doctor will delay the treatment for a week to a
maximum of two weeks, beyond which, the patient will be taken off the trial. If there is a
delay of more than one week or the study participant has significant side effects, their
doctor will decrease the dose of the carboplatin and docetaxel. During the treatment period,
doctors may also prescribe medications to treat low red blood cells or low white blood
Before each cycle (every 3 weeks), there will be routine blood tests drawn (about 3
teaspoons) to monitor bone marrow, liver, and kidney functions. These samples will look at
two proteins in the blood and may help us predict who will respond to docetaxel and
carboplatin. We will also obtain CT scans after every 3 cycles of treatment and at the end of
the study. A bone scan will also be done after every 3 cycles if there was evidence of bone
involvement on the first bone scan. A bone scan may also be ordered during the study in
patients without prior evidence of bone involvement if the doctor suspects that the cancer
has now spread to the bone.
Minimum age: 18 Years.
Maximum age: N/A.
- Histologically confirmed adenocarcinoma of the prostate
- Evidence of metastatic disease
- Disease progression following androgen deprivation therapy
- Disease progression despite docetaxel-based chemotherapy
- Serum testosterone levels less than 50ng/ml (unless surgically castrated). Patients
must continue androgen deprivation with a luteinizing hormone-releasing hormone (LHRH)
analogue if they have not undergone orchiectomy.
- No use of antiandrogens for at least 4 weeks
- Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2
- Acceptable white blood cell (WBC), platelets, creatinine and AST counts
- Significant peripheral neuropathy defined as grade 2 or higher
- Within 4 weeks since completing external beam radiotherapy or 8 weeks since completing
radiopharmaceutical therapy (strontium, samarium)
- Prior platinum-based chemotherapy (cisplatin or carboplatin) for hormone- refractory
- Concomitant chemotherapy, investigational agents or systemic steroids
Locations and Contacts
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Lowell General Hospital, Lowell, Massachusetts 01854, United States
Wentworth Douglass Hospital, Dover, New Hampshire 03820, United States
Oregon Health and Science University, Portland, Oregon 97239, United States
Starting date: January 2004
Ending date: April 2008
Last updated: December 22, 2007